GKTClass II

Separator, Automated, Blood Cell, Diagnostic

Hematology · 21 CFR 864.9245

MDR events6,575All time

Recalls1All time

Registered firms288Currently listed

510(k) clearances10All time

Recent MDR events

6,575 adverse event reports on file

Event type breakdown

Malfunction5,078

Injury931

Death264

Unspecified216

Other86

Most-reported manufacturers

Terumo Bct5,099 Haemonetics Corporation312 Baxter Healthcare Corp.294 Haemonetics Corp110 Caridianbct92 Haemonetics Corp.73 Fenwal International Inc.72 Sanmina72

Recalls

1 recall events for this product code

Fenwal Inc
TerminatedUnknown
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
Z-1343-2021 · View FDA record ↗

Registered firms

288 firms currently registered for this product code

510(k) clearances

10 clearances for this product code